Cerulean flunks another Phase 2 trial
- Cerulean Pharma's Phase 2 drug for renal cell carcinoma missed its primary endpoint when tested in combination with Avastin (bevacizumab).
- The trial included 115 patients who had previously used two other cancer agents at 43 sites across the U.S. and South Korea.
- CRLX101 plus Avastin missed both the primary endpoint of progression-free survival, as well as the secondary endpoint of overall response rate when tested against the standard-of-care.
The drug failed previously in 2013 – not only missing endpoints, but doing much worse than the standard-of-care. Management blamed trial design and has been trying to redeem itself since.
Investor trust is at an all-time low. Shares of the company dropped more than 63% in after-hours trading Wednesday, pushing the stock to trade near just a $1 per share. The stock is well off its 52-week high of $5.20.
The failure was just as spectacular the second time around. The two drugs actually performed worse than the standard-of-care (SOC) that they were being tested against, showing a progression-free survival of just 3.7 months compared with 3.9 for SOC. Meanwhile, the overall response rate was also well below, coming in at just 5% compared with 14% with SOC.
CRLX101 uses a nanoparticle technology that is meant to make highly toxic chemotherapies safer. Cerulean isn't giving up; the company intends to continue ongoing trials of the drug in combination with other therapies.
"This outcome did not support our hypothesis that targeting hypoxia inducible factor (HIF) in combination with VEGF inhibitor in RCC, a HIF-overexpressing tumor type, would be beneficial, so we will not pursue HIF as a target going forward," said CEO Christopher Guiffre in a statement.
The company will continue to pursue development in tumors that express other sensitivities.
"Our combinations with weekly paclitaxel and Lynparza (olaparib) are examples of ongoing trials that leverage CRLX101’s topoisomerase 1 inhibition in combination with chemotherapies and DNA damage repair agents," he added.
Cerulean only had about $47 million in cash on hand at the end of the second quarter, giving it a runway of about 12 months.
- Cerulean Pharma Statement
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